Q4 2019 Earnings Call
Ladies and gentlemen, good this the alternator today's conference just cut just good momentarily until that time. Your line. So what can be placed on hold picky for your patience.
Ladies and gentlemen, this is all theater to piece conference just coach it's a good momentarily until that time your lines what can be placed on hold thank you for your patience.
[music].
Afternoon, and welcome to todays conference call for Omeros Corporation at this time, all participants are in to listen only mode.
The company's remarks, who will conduct a question answer session. Please be advised that this call is being recorded at the company's request an replay will be available on the company's website for one week something.
Oh sure, though with coal to Jennifer Williams Investor Relations for America.
Good afternoon, and thank you for joining the call today I'd like to remind you that some of the statements that will be made on the call today will be forward. Looking these statements are based on management's beliefs and expectations as of today only and are subject to change all forward looking statements involve risks and uncertainties that could cause the companys actual results to differ materially. Please.
We refer to the special note regarding forward looking statements in the Companys 2019 annual report on form 10-K, which was filed today with the FCC and the risk factor section also in the company's 2019 annual reports for a discussion of these risks and uncertainties.
Dr., Greg Demopolis, Chairman and CEO of Omeros will take you through a corporate update and then Mike Jacobson, Our Chief Accounting Officer will provide an overview of our financial results. We have some time reserve for questions. After the financial overview now I will turn the call over to Dr. Demopolis.
Thank you Jennifer and good afternoon, everyone. We appreciate you joining us for todays update as you likely saw we issued a press release today on the data from our nor supplement pivotal trial and hematopoietic stem cell transplant associated thrombotic microangiopathy or stem cell PMAG all start todays call.
With a brief summary of our financial highlights and then immediately run through our in our supplemental data.
Net sales of Omidria in the fourth quarter were $33.4 million. Another new record. This represents a 52% increase compared to the fourth quarter of 28 team and a 12% increase over last quarter.
It's important to note here that wholesaler inventories at December 31, 29 team were consistent with those historically held at year end by our wholesalers.
Our net loss for the fourth quarter of 2019 was $29.2 million or 58 cents per share.
This includes noncash expenses of $6.3 million or 13 cents per share.
This also includes a onetime charge of $12.6 million or 25 cents per share due to our accelerating into the fourth quarter. That's successful manufacturer of a set of five lots of non stop them out, but lonza, including three process validation lots.
These lot satisfy F.D. is requirements for our be away and all of these lots will be available for commercial sale following approval.
Under GAAP accounting manufacturing costs incurred prior to regulatory approval are expensed as R&D as a result, there will be almost no cost of goods realized when these lots are sold.
So when we net out the noncash expenses on the onetime manufacturer of PV lots, our overall cash burn for the quarter was approximately $10 million.
As of yearend, we had approximately $61 million with cash and investments available for general operations. We also have a 50 million dollar accounts receivable base line of credit, which allows us to borrow up to 85% of our eligible accounts receivable.
Now, let's get right to our MASP two antibody in our supplemental data from our pivotal registration trial in stem cell T I may patient.
Enrollment in the pivotal trial was stopped with the agreement of F.D.J.F.D.A.S. satisfied that the number of patients enrolled and that the data generated are sufficient to submit our rolling biologics license application or B.L.A. for this breakthrough therapy designated product and the first.
Actions were submitted to F.D.A. last quarter.
There is no approved treatment for stem cell, Tim and our first objective for an hour supplement is to obtain approval for this often leasehold disorder as quickly as possible.
The data from our pivotal trial, which were summarized in today's press release speak strongly to the approval question.
Before jumping into the data I'd like to thank the patients their families. The physician investigators another caregivers who participated in our trial.
Your efforts our sincerely appreciate it and together I expect that we've significantly improved the lives of future stem cell transplant patients.
Now, let's look at the data a two important aspects of our stem cell Tim a program. Our one the definition of the primary endpoint and to the threshold for meeting that endpoint as we have previously discussed omeros worked with half D.A. reviewers to develop a clear definition of response.
That demonstrates meaningful benefit and the variable population that we studied.
As described in detail in today's press release, the FDA agreed definition of the primary endpoint provides a rigorous test of efficacy and patient benefit.
The FDA agreed response threshold up 15% demonstrates the severely ill nature of our patient population and their elevated risk of poor outcomes.
Patients in the trial had a high expected mortality rate, but 93% of them, having multiple risk factors, including the persistence of stem cell Tim made despite modification of immunosuppression, which itself was a criterion for entry into the trial.
Graft versus host as is significant infections, noninfectious pulmonary complications and neurological findings.
28 stem cell Tim a patients were enrolled in the trial and received at least one dose of nor supplement.
54% of patients in this intend to treat population met the FDA agreed complete response primary endpoint and 65% of patients who receive the protocol specified treatment of at least four weeks of dosing were complete responders.
Both of these response rates are well above the FDA agreed 15% threshold for efficacy.
The 95% confidence center for all patients is 34% to 72% and for those who received at least the protocol specified four weeks of dosing the 95% confidence interval is 43% to 84% in.
Both populations these translate to P values less than 0.0001.
The secondary endpoints of 100 days survival was equally impressive 68 patients across 68% across all patients 83% in the protocol specified treatment group and 93% in responders.
[noise] laboratory assessments of secondary efficacy endpoints also demonstrate meaningful and statistically significant improvement with P values less than 0.01 across all patients on change from baseline for platelets LDH and have to global.
And our sample amount has been well tolerated across our development programs and the stem cell TDMA trial. The most commonly reported adverse events were diarrhea, nausea, vomiting, hyperkalemia neutropenia and fever, all common in stem cell transplant patients.
Six deaths occurred during the trial.
These were due to sepsis progression of the underlying disease and graft versus host disease again, all common causes of death in this patient population.
At the American Society of Hematology meeting in Orlando in December we had the opportunity to discuss data from our trial with over 30 of the Premier transplant physicians throughout the U.S. in Europe.
Similarly at the recent transplant and cellular therapy conference also in Orlando data on our supplemental been stem cell TDMA were shared both at a continuing medical education Symposium and with an advisory board comprised of some of the top transplant opinion leaders in the U.S.
Feedback on the clinical data was uniformly and highly positive.
Complete clinical trial data will be presented by Dr. Miguel paralysis, Deputy chief of the adult bone marrow transplantation service and director of the adult stem cell transplantation Fellowship at Memorial Sloan Kettering Cancer Center at the upcoming annual meeting of the European Society for blood and marrow transplant.
Station in Madrid later this month.
Now, let's discuss our progress on chemistry manufacturing and controls are CMC.
In February of this year Omeros met with FDA to discuss the CMC aspects of the desktop Lamar BLS.
At the meeting FDA requested near term manufacturing dates for in our supplemental so that F.D. is preapproval inspections could be schedule.
FDA panel Merrells also reached agreement on requirements for stability data and release assays for the BLM.
As previously mentioned together with our manufacturing partner Lonza, we have completed successful manufacturing of the required process validation lots of nurse awful amount to include in the B.L.A.
These were completed ahead of schedule to accelerate the B L. A timeline.
All of the completed in our supplemental lots will be available for commercial use.
Timing for submission of the CMC sections of our Bill a remain on track.
The nonclinical sections of the Rolling B.L.A. were submitted to FDA last quarter.
The remaining sections of our B.L.A.'s CMC and clinical are progressing well the clinical sections of the B.L.A. will include the standard clinical study reports and clinical modules.
All clinical trial data have been compiled and are already in house out Omeros.
As initially requested by FDA in connection with our breakthrough therapy designation omeros, including in the B L. A detailed narratives on all patients.
These narratives supply additional historical information that was not collected in the clinical trial, such as the clinical course prior to participation in the clinical trial.
Most of the historical data needed to round out the patient narratives have already been collected.
Importantly, all data affecting our efficacy endpoints are already compiled and in house settle merrells and are reflected in the efficacy data provided today.
We encountered and administrative delay in one country related to local law requirements for the collection of historical data on deceased patients.
Which prohibit any post mortem collection or transfer of historical data until government authorization has received.
That issue appears to be resolved in the process of historical data collection at that site has begun.
The administrative delay however may cause our clinical submission to slip into the early part of the third quarter. We're assessing the logistics of several options to bring the full submission date in earlier.
Our preparations for the commercial launch of nurse up till now been stem cell Tammy also continue to progress.
As we've reviewed on previous calls the value story behind in our supplement is strong.
Our efficacy profile goes beyond a complete response number the profile represents saving lives and reducing cost of care, including hospital admissions intensive care units days and dialysis.
Feedback from us and European transplant administrators, and payers also stressed the importance of how in our supplemental abuse would fit within their current treatment paradigms.
As a 30 minute infusion administration as easy for them and would dovetail into their existing treatment framework for both the inpatient and outpatient settings.
During 2020, we will continue to build out our commercial team to prepare for the anticipated U.S. launch.
These strategic hires will be timed around milestones to ensure that we are fully ready to launch in our supplemental for patients suffering from stem cell Tms.
Regarding our European marketing authorization application or M&A last quarter, we received a positive opinion from the pediatric committee of the May for our pediatric investigation plan or Pip foreign our supplement.
This positive opinion was adopted by M. A C H MP, a prerequisite to emmys acceptance of an M&A through the centralized procedure.
As we noted successful completion of the Pip Maixner supplement eligible for up to two additional years of marketing exclusivity and in many will also allow us to defer completion of the pediatric plan until after approval of the M&A.
We are currently focused on completing the BLS submission to the U.S. and we plan to complete the submission for European marketing approval. After the BLE has been filed.
Well stem cell Tim is our initial focus this disorder as part of a constellation of endothelial injury syndromes, which include graft versus host disease, Beano, occlusive disease, or sinusoidal obstruction syndrome, diffuse alveolar hemorrhage, idiopathic pneumonia syndrome and others.
All of these syndromes are thought to be caused by endothelial damage, which is known to activate the lectin pathway of complement.
Mass to is the effector enzyme of the lectin pathway. So in our supplemental could well be effective across endothelial injury syndromes, and we plan to evaluate and our supplement in a number of them.
Let's turn now to our phase three program for in our supplement idea in a property which continues to progress.
In our Artemus I began phase III trial, we are enrolling both from the general population of patients with at least one gram of proteinuria daily.
And from the subset of patients with 24 hour proteinuria levels greater than two grams.
We expect data read out next year.
A manuscript was prepared bio Marist as academic leadership Committee, which is comprised of world leaders and I Jana for apathy in Reno clinical research.
The manuscript detailing the clinical data from the phase two I Jane and property program is expected to be published in a premier peer reviewed journal also a review article entitled Mass to inhibition as potential strategy for idea in a property management authored by Dr., Jonathan Veritiv University of Lester and rich.
Sure Lafayette of Stanford University will soon be published in the journal drugs of the future.
Chronic subcutaneous dosing of Marsal AMAP is being used in our phase three trial for atypical hemolytic uremic syndrome, or a chew Wes.
The trial includes multiple sites in the U.S. Asia and Europe.
And is actively enrolling as previously noted the bulk of our supplement related resources are focused on some tell TDMA and digesting a property and we expect this program to complete after both T M. A anti GA.
Now, let's move onto Omidria RF da approved the filmic product as is evident from our fourth quarter results demand for Omidria continues to grow both across hospitals and day as sees.
Hey, assays sale growth continued to be driven by increasing penetration in existing accounts and expansion to new accounts.
Hospitals sales in the fourth quarter were particularly strong.
And for the first time since reintroduction, we saw a higher growth rate and hospitals than analyses. This is an encouraging development hospitals represent not only a significant opportunity to grow omidria sales. They also allow us to demonstrate omidria as benefits and improved out.
Comes to future cataract surgeons training in these facilities overall in the fourth quarter, we saw a greater than 10% growth and the number of purchasing accounts over the previous quarter.
Fourth quarter sales also benefited from the introduction of our new J code, which became effective October onest.
J codes standardize the submission and payment of insurance claims across Medicare Medicare advantage, Medicaid and commercial insurance plans.
The early results indicate that our new J code will be important to own merger as future.
Providing expanded reimbursement across all payers and sites of care.
Numerous plans that previously would not cover omidria under our prior C code are now reimbursing under the J code.
The J code also provide separate coverage for omidria when used in the setting of the physician office, where a growing number of cataract procedures are performed.
This is important for two reasons first our previous C code was not reimbursed in the office setting and second this setting is one in which CMS is mandated to pay separately for Omidria independent of pass through status.
With respect to CMS, Medicare part B and pass through the current pass through reimbursement status for Omidria is slated to expire on September 30 of this year.
We continue to pursue broad base legislative and administrative efforts to secure payment for Omidria beyond September 30, and we remain optimistic that we will be successful.
On the legislative side, the non opioid prevent addiction in the Nation Act referred to as the no Pain Act was introduced in the fourth quarter in both the house of Representatives and the Senate. This bipartisan legislation is designed to remove payment disincentives put in place by CMS that currently risk.
Eric the ability of practitioners to prescribe non opioid treatment alternatives in surgical settings.
With seven Senate and 16 house bipartisan sponsors and co sponsors the no pain Act is gaining momentum.
Supported by the congressional bipartisan opioid task force the no pain Act also enjoys strong advocacy from grassroots organizations led by voices for non opioid choices and is supported by a diverse coalition, including professional organizations of physicians and nurses and.
Other groups fighting for commonsense solutions to pain management.
If passed the legislation would provide separate payments status for five years.
And as an anecdotal complement to the measurable legislature progress we're seeing in the past several months. We've also witnessed a steady course of third party advocates columnists physicians and think tank types supporting Omidria Medicare coverage. Some recent examples of pro Omidria piece.
And as we've seen our in mainstream publications, such as Investor's business daily in the Washington, and times as well as an important health care and policy publications, where the policy makers get their news.
Such as modern healthcare the hill inside health policy fares health care.
Morning console, Helio and real clear health.
We're also pursuing administrative effort to qualify omidria for continued separate payment under the non opioid exclusion that was established by CMS in response to Congress as mandate under the support Act.
The non opioid exclusion enable CMS to pay separately for non opioid pain management drugs administered during surgery that CMS would otherwise package under its drugs as supplies package and policy.
As CMS requested we continue to generate evidence demonstrating that Omidria falls squarely within the non opioid exclusion, including evidenced that use of omidria is associated with lower use of opioid both during and after surgery.
Among other efforts a team of data scientists armed with IBM Watson technology are providing analytics on claims data from a large number of cataract procedures and demonstrating that use of omidria and cataract surgery reduces the quantity of opioids prescribed post operatively.
Further as mentioned during our third quarter update Dr., Eric Donenfeld clinical professor of Ophthalmology at New York University in recent past President of the American Society of Cataract and refractive surgery published a study and the peer reviewed journal clinical ophthalmology, demonstrating that omidria resulted in a reduction in both.
Fentanyl use and VA chest pain scores.
Another clinical trial is currently underway to demonstrate omidria as opioid sparing abilities.
With a growing volume of published data on the benefits of Omidria utilization of the drug continues to expand across Medicare part B med advantage and commercial patients as well as in the V.A. system and academic centers.
Omidria is now on formulary in five of the top six and 11 of the top 17 academic centers for ophthalmology training, including the number one rank training program in the country Baskin Palmer Eye Institute at the University of Miami.
Of course patient safety and reduced rates of surgical complications are a critical concerned the surgeons facility administrators and patients.
In Dallas lawsuits were filed against the surgeons facilities and the compounding pharmacy, because the surgeons have used a compounded product that caused a vision loss in at least 68 cataract surgery patients.
Recently, a large number of the cases were settled underscoring that use of compounded products instead of that FDA approved products like Omidria present, not only grave physical risk to patients, but also serious financial risk two facilities physicians and their surgical pro.
Back to says.
Imagery is the only FDIC approved product of its kind in the absence of separate payment for the drug surgeons and facilities are relegated to using less safe compounded products incurring significant potential financial liability.
Now, let's turn to all investment I know six another major component of our complement franchise.
Almost 906 as our antibody targeting mass three we along with others in industry and in the complement research community believe that MASP three is the key activator and premiered drug target in the alternative pathway.
To understand the breadth of potential indications for all nine of six.
One need only look at the indications pursued by other alternative pathway inhibitors.
Our initial focus is on paroxysmal nocturnal hemoglobin urea or Pn H, where we expect to have significant advantages over other complement inhibitors approved or in development.
These include the ability to inhibit extra vascular homologous, while providing more potent inhibition of intravascular homologous a favorable safety profile and a more convenient route of administration with much lower frequency of self administered dosing.
Preliminary toxicology results show no adverse effects, even at the highest dose tested.
Almost 906 remains on track to enter the clinic next quarter.
Beyond our supplemental a mess nine or six our strategy for lifecycle management of our complement franchise is progressing nicely.
Our longer acting second generation antibody against mass to as planned for clinical entry in early 2022, followed by an orally available small molecule inhibitor against MASP two.
We also are developing small molecule inhibitors of MASP three.
Now, let's discuss briefly our phosphodiesterase seven or PD seven program to treat addictions and compulsion.
In our phase one trial, which completed last fall our drug was well tolerated with good safety. It's PK profile was consistent with once daily dosing taken with or without food our focus as nicotine addiction, and we are planning our phase two development program.
Let's close our pipeline discussion with an update on our G protein coupled receptor or GPCR program.
Last quarter Omeros presented data at conferences in Boston and Geneva, demonstrating a link between features of the tumor micro environment and GPR 174 mediated suppression of anti tumor immune responses.
We found the GPR 174 is stimulated by phosphate titles searing, which is highly abundant in tumors.
Sell membranes, exposing phosphate titles hearing activate GPR 174 on T cells.
Resulting in suppression of T cell functions like the release of interleukin two and interferon gamma.
Both required for the effective killing of tumor cells.
We have found the GPR 174 deficient mice are more effective that controlling tumor growth in models of melanoma and colon cancer and the presence of an immune stimulating co therapy.
We currently are evaluating the impact of GPR 174 inhibition in tumor models in mice reconstituted with the human immune system.
Another product of tumor cell death found in high concentration in tumors as adenosine, which signals through immune cell gpcrs similar to GPR 174.
These adenosine receptors a two way in a to B are thought to play a significant role and patient resistance to immune checkpoint inhibitors, such as of devote keytruda and yervoy.
We have found that in the presence of fossil title Syrian ended denizen.
Inhibition of both GPR 174, and adenosine receptor is results in synergistic and complete restoration of the production of the tumor cell killers aisle to and interferon gamma.
We are currently assessing the effects of the combined GPR 174, and adenosine pathway inhibition in animal tumor models.
With our proprietary GPR on 74 inhibitors in this new understanding of how tumors suppress the immune system.
Omeros as well position to bring novel and transformative cancer immunotherapy strategies to the clinic.
Before handing the call over to Mike for an overview of our fourth quarter financial results I'd like to welcome Kurt Zumwalt to our board of directors.
Kurt as the former treasurer of Amazon, obviously accomplished with a strong network of financial context. He's also a really good guy and we look forward to working with Curt and expect that it will play an important role in our ongoing growth.
Mike.
Thanks, Greg.
As Greg noted Omidria in total revenues for the fourth quarter were $33.4 million and our net loss was $29.2 million or 58 cents per share.
This includes noncash expenses of $6.3 million or 13 cents per share.
The increase in our net loss from the prior quarter was driven by the accelerated and successful manufacture a process validation and commercial lots of in our supplement at Lonza, our CMO to support the CMC portion of our B.L.A. filing for stem cell TDMA.
This represents a one time 12.6 million dollar expense or 25 cents per share and will save us an equal amount. If then went all the lots are sold commercially following approval.
After netting out the noncash expenses and the onetime manufacturer of than our Sop of Mab loss, our overall cash burn for the fourth quarter was approximately $10 million.
As of December 30, Onest 2019, we had approximately $61 million of cash cash equivalents and short term investments available for general operations.
We also have an accounts receivable base line of credit, which allows us to borrow up to $50 million based on 85% of our available accounts receivable borrowing base.
Here are some additional details regarding our fourth quarter results compared to the third quarter.
Revenue for the fourth quarter increased 3.6 million from the third quarter and benefits benefited from the introduction of the new J code that became effective October onest.
Which replaces the previous C code.
We anticipate that the new J code will help our overall reimbursement for procedures covered under Medicare advantage and commercial insurance plans as we continue to move through 2020.
Our fourth quarter gross to net deduction was 27% compared to 28% in the prior quarter.
Cost and expenses for the fourth quarter were $57 million or 16.6 million more than the prior quarter.
Again, the increase was driven largely by at scale process validation and commercial lots at Lonza.
The manufacturer of these batches accelerated Q4 to align better with our B L. A timeline.
We're also assessed fully manufactured and are expected to be used primarily for commercial supply.
As you may recall until we receive approval for Necitumumab and stem cell TDMA.
All CMC related costs would normally be included in inventory ours expensed as incurred.
Going forward, we do not expect to incur similar costs until we build additional commercial inventory furnace up of Matt.
In the second half of 2020.
Interest expense for the quarter was $5.8 million and inline with our expectations.
Looking ahead to the first quarter of 2020 and beyond we anticipate that our mid do revenue will continue to increase during periods that we have permanent separate reimbursement.
As Greg discussed earlier, we're pursuing both administrative been a legislative means to achieve permanent separate reimbursement.
And believe we will be successful.
That said it should be noted that first quarter of the year has historically the first the fewest number of cataract procedures performed.
Our research and development expenses for the first quarter will be down considerably from the fourth quarter.
SGN egg costs are also expected to increase across the year as we prepare for the launch of in or supplement.
We plan to higher medical affairs specialists in the second quarter and begin hiring sales representatives in the third quarter.
With that I'd like to turn the call back over to Greg Greg.
Thanks, Mike, Let's open the call to questions.
Ladies and gentlemen, if you have questions at this time. Please press Star then one key touched on telephone.
Your question was being answered you wish to remove yourself from the Q. Please press the pankey.
Our first question comes from the line key frozen WPP Your line is.
Great.
Great. Thank you for taking the question and obviously congrats on the quarter in the year two questions. The first one.
Going into no supplement you've explained the decision that you made on the acceleration of manufacturing can you position. This.
And give us as much color as you can on how this affects the rolling BLE and what it means and what the other parts or so that we can gauge how much you completed and what you're looking at into the future.
Sure. Thanks, Steve.
Well certainly our objective is to get the product.
Approved which will require us submitting the BLM as quickly as possible. So what we wanted to make sure was that.
Our manufacturing aligned.
As best as possible with that timeline.
I think it demonstrates certainly.
Hi level of confidence that we have here.
Around the.
Potential for this product commercially and also I think for what we see is the.
Likelihood of success in the approval process.
Okay.
You are going back to obviously everything that you've spoken with FDA.
One question I really wanted to just get some more sense of on the clinicians what kind of anecdotal information that did you come up with or did they provide to use obviously right now you're collecting additional data I'm just kind of curious to see with what they were saying given how devastating diseases.
Sure. Thank you.
Look we've had a number of patients.
Again, when you say anecdotally remember that these these anecdotal patients have have all collectively formed a clinical trial with with the data that we've just released but we've we've spoken publicly about the young Italian patient we've spoken public.
Lastly, or are.
Our experts.
In this field have spoken publicly about I believe patients in Spain.
And others. So I think that collectively the anecdotal data have created the very strong data that we released today.
And again I mean, when you look at their response rates versus the FDA agreed threshold.
I think it's it's an impressive.
Set of data that we have provided and I think we've done it in in full transparency. So every piece of that just about every piece.
We're saving some of this for what comes out of the BMT as well, but I mean, I think that we've answered just about every question that anyone could have.
About the the pivotal trial.
So to your point taken a P value point.
Well one.
He is not anecdotally I get it.
Okay.
Let me, let me ask one last question and I'll hop back on the Q.
And something it was really fascinating.
How with with Omidria that you'd start to see hospitals are starting to use it and as much as you can given the fact that hospitals do have residencies, where that's the training ground for future clinicians in the field.
What can you tell us about that because it's one of things where I'm always kind of curious to see how it's being the uptick being taking their and and then I'll hop back in the queue. Thank you.
Sure. Thanks, Dave.
Well, we've had a growth in hospital sales for awhile.
What we reported today was just that this was the first time that that growth had exceeded the growth in the sees the growth in overall across hospitals analyses was over 10% growth in new customers I mean, I think thats, an important statistic thats, telling you that were not just.
Expanding by drilling deeper into our existing customer base, but that were actually expanding customer base and in this case by over 10% you're absolutely correct in your perception of how hospitals play into future growth.
Hospitals are the sites where.
Residence tray.
And that's why we also provided the data that we provided specifically on the academic centers, where now five of the top six on 11 of the top 17 academic centers for about mix surgery have omidria on formulary use omidria and that now includes the none.
For one ranked center, which is bascom Palmer.
Yes.
The feedback we get is that the product is extremely helpful. In the hospital setting with the residents and with a resident training.
And as I think we all understand that.
What you do during your training you often do when you leave training.
And I think that this is why we find this increase in the in the hospitals.
So encouraging to the overall future of Omidria.
Great again, thanks, and congrats look forward to obviously 2020.
Yes, Thank you Steve.
Your next question comes from the line of put themselves with H.C. Wainwright. Your line is open.
Good afternoon. This is Edward marks on for Rob I. Appreciate you guys taking questions.
Looking at Omidria I'm, just wondering has the likelihood of past reimbursement extension changed for the worse in recent weeks due to some potential budget constraints around krona virus or do not see this having any bearing on the process.
Thank you, yes, I don't think that has any bearing.
I think that if anything the growth.
Of the support and the increase in momentum around.
Around our legislative and administrative efforts.
Indicate quite the opposite.
I think that when you look at.
For example, the no pain Act and this is just one example, but when you look at the no Pain Act you are seeing an increasing number of sponsors and co sponsors both in the house and in the Senate and remember that it's not just quantity, even though that quantity is increasing in both chambers and I should underscore.
No we spoke about this in the prepared comments, but this is truly a bipartisan.
Bill This has effectively equal support so sponsors and co sponsors IEC effectively equally divided between both parties.
And that that is growing so it's not just the quantity, though but it's also.
Our youre sponsors on key committees, both in the house and in the Senate. So I think that it's it's the.
It certainly is helpful that this is the right policy.
I mean, certainly this is something that should be done it's something that I think both parties one of the few things maybe that both parties in in Congress.
Great.
And so I think in short answer to your question I think it's quite the opposite I think what we're seeing is movement toward getting this done as opposed to somehow or another impediment.
Placed in front of it.
Well, that's certainly good to hear.
And moving on to our supplement.
Do you have any additional color and when the Optimists again trial will provide some top line data and specifically with the FDA wanted to see this topline data before the approve.
Stem cell teammates.
First we guided to next year, and we'll be able to dial that in a little better as we progress through this year.
As I said, we had what I think 91.
Clinical trial sites open and running around I, Jay nephropathy, and more coming online we're we're quite.
Happy with the increase in enrollment that we're seeing.
And remember that we are going to be looking at both the general population and the.
Subset of high protein spillers, so those that are putting out one gram a day those that are putting out two grams, a day and you know.
I believe that we are the only company specifically looking at those high protein spillers.
And our AR.
Data assessment will be on both of those on both of those groups.
With respect to your second question no I do not think at all that there is any length whatsoever between Tim may and the assessment of our TM may data for approval in the idea did I think the and I think I understand your question I'm I'm.
At least I think I do that you're wondering about the safety of the product and I think that weve established that pretty clearly so no I don't see any connection between those two I think they'll be reviewed independently as the data are submitted.
Okay and yes. They did have that question right. So thank you for the detail, yes, we have not seen we have not seen a.
Drug related.
Serious adverse event with.
With the nurse up from that.
Okay.
Two more quick ones here just on that program.
You put out late at the nice complete response.
Threshold data I'm wondering if there is an FC efficacy threshold for one hundredg survival instant fill TDMA or is there no agreement with the FDA on this point before.
Could you repeat that last question I'm, sorry, it broke up.
Yes.
So just wondering what is the FDA efficacy threshold for 100, a survival instance, LTM a or do not have agreement with the FDA on this point yet.
No. It's a secondary endpoint, we're not going to two need.
A threshold for that I think it's pretty clear, though the experts.
Believe that.
These patients should have had a less than 20% 100 day survival and what you're seeing are the the data that we generated what I believe it's.
65% and the in the.
In all patients.
80.
83% in the.
Protocol specified for dose and 93% in the response group. So those numbers are however, you turn them or look at them or cut them. Those data are are extremely impressive and when you again balance the benefit risk.
Here.
As I mentioned we.
We really have not seen a meaningful safety signal with.
With.
In our supplement.
Right and then just the last quick question I'm wondering how many patients do you expect to beyond their supplement through your work with my Tomorrow's program.
Yes, that's it's a question one that I'm not going to to answer right now that's a shade compassionate use program that we have running with my tomorrow's and that sort of information. We're just generally not putting out there for for reasons that.
You will understand.
Absolutely.
Thank you I appreciate all the details and congrats.
Thank you very much.
Your next question comes from the line is secured spilling Joe with Needham and company. Your line is open.
Hey, Thanks, David Channel for Surgeons had a couple of questions. So the first one is about the pass through status. So as we approach the exploration in about six month.
How do you expect the sales for a major that's a trend beyond September if.
Theres any theres no extensions should we expect something more in line to what we saw in 2018 or potentially a little bit better.
Now that it's a more established product in the hospital in the assay settings.
Right I would agree with what you just said we would not expect to see the same sort of decrease that we saw.
When the original pass through came off at the end of 2017 so.
This is a product now that has significantly more data published around it we.
We would expect the sales to continue.
To ramp we think.
Through.
Through.
The next couple of quarters, and we'll have to see we were not placing all of our bets on an extension of pass through.
We think that that will be successful, but you would also expect that we have built.
Multiple backup plans to that one.
And that expectation would be correct.
Okay, great. Thanks, and then just on the impact and the penetration of the J code can you just described a little bit more in detail in terms of the penetration that you've seen on the commercial.
The Medicaid Medicare advantage here, so far and how how do you expect this trend to play out in 2020 and beyond.
Right, we have seen as I said an increase of.
Plans reimbursing under the J code that were not reimbursing under the C code and Thats cutting across med advantage and commercial plans, we would expect that trend will continue to increase.
As physicians continue to contact their payers and.
And does.
More and more of these med advantage and commercial payers are reimbursing.
Both regionally and nationally.
For Omidria.
Great and then that would include both not only the number of plans reimbursing, but the amount.
That they do reimburse.
Great and then lastly, just on.
Seven to one.
Is there any feedback or update from the FDA as far as the priority review status is that something that you're still thinking about for six months with you.
Sure, Let me turn that question over to.
Over to our Chief regulatory Officer, Kathy Melfi.
Sure Hi, Thanks for the question regarding priority review again, that's something that's determined at the time of filing we'd certainly apply for it and we've spoken at the about it and given our breakthrough therapy designation.
FDIC has agreed that typically we would be granted a priority priority review. So again, we are expecting it but it wouldn't be official until we have the submission and the final ruling by the FDA.
Great. Thank you for the details.
Your next question comes from the line of credit folks at Cantor Fitzgerald. Your line is open.
Hi, Thanks for taking my questions and congratulations on the quarter and the data and.
Could you just help us think the timeline from here to approval for diplomat in terms of you say that we will see from outside I know you talked about.
The potential for the clinical submission in any part of Threeq Twentytwenty.
What else and should we expect between now and hearing thank you.
Well with respect to the timeline, we first thing we'll need to do is.
Complete the clinical section as well as the CMC sections and submit those two F.D.A. once that's been filed as you know Brendan.
The FDA has six months from the data filing.
And.
But you have also recently seen that F. da has acted more quickly.
In some situations than that so we'll have to see how all that how all of those pieces come together for for the full timeline.
Our priority. In addition to getting this submitted is to submit it a quality BLE and one that will not come back with with questions that would be time time consuming.
So we want to make sure we submit a quality product I fully expect we will based on the data that we have and the work.
By this team that has already gone into it.
I have really no doubt about that and we'll just see.
How that how that timeline moves following following filing.
Great. Thank you congratulations again.
Thank you brand.
Dan I'm showing no further questions at this time I would now like turn the conference back itself.
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Thank you operator, and that wraps up our call for today.
Thank you again, everyone for taking the time to listen it.
We're proud of what we accomplished as a company in 2019 and are very appreciative.
Our shareholders for their interest and support.
At the heart of everything we do it Omeros is really a devotion to improving the lives of patients and their families our employees.
Really do live that mission, each day and I'd like to thank them.
And all our advisors and collaborators for their collective contributions to our success last year and to our expected continued successes in 2020 as always.
Appreciate your support and have a have a good evening.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.
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